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Bayer HealthCare CERTEGRA MEDRAD Stellant FLEX User Manual

Bayer HealthCare CERTEGRA MEDRAD Stellant FLEX
112 pages
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Operation Manual

Table of Contents

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Bayer HealthCare CERTEGRA MEDRAD Stellant FLEX Specifications

General IconGeneral
Device TypeContrast Delivery System
Pressure Limit325 psi
Power Requirements100-240V AC, 50/60Hz
DisplayTouchscreen LCD
Power SourceAC Power
ApplicationCT Imaging
Number of SyringesDual
Syringe Capacity200 ml
Flow Rate Range0.1 - 10 ml/sec
ConnectivityEthernet
Injection ProtocolsProgrammable
TypeInjector System

Summary

MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation

Operation Manual

The primary manual detailing the operation of the system.

1 Introduction

1.1 Certifications

Device certifications and compliance standards.

1.2 Intended Patient Population

Description of the intended user patient group.

1.3 Indications For Use

Specifies the intended medical applications for the device.

1.4 Contraindications

Lists conditions where the device should not be used.

1.5 Restricted Sales

Information on legal restrictions for device sale.

1.6 Required Training

Details the necessary training for operating the device.

1.7 Disclaimers

Bayer's liability and user responsibilities.

1.8 The Equipotential Connector (EPC)

Explanation of the EPC for electrical bonding.

1.9 Installation

Instructions or contact for system installation.

2 Symbols

2.1 General Symbols

Explains standard safety and informational symbols.

2.2 Injection System Buttons and Icons

Identifies system controls and graphical elements.

3 Warnings, Precautions, and Notices

3.1 Warnings

Critical safety information regarding potential injury or death.

3.2 Cautions

Information about potential minor injury or moderate harm.

3.3 Notices

Information regarding potential equipment damage.

4 System Overview

4.1 System Diagram

Visual representation of system components and connections.

4.2 Fluid Delivery Basics

Fundamental principles of fluid injection.

4.3 Syringe Installation Features

Describes features aiding syringe loading.

4.4 Programming Mode

Explanation of how to set injection parameters.

4.5 Basic Informatics

Overview of optional informatics features.

4.6 Using the Pedestal with Integrated IV Pole

Guidelines for using the system's support structure.

5 Understanding the Display and Workstation

5.1 Home Screen

Description of the main operational interface.

5.2 Workstation Descriptions

Details of the workstation's controls and displays.

6 Understanding the Injector Head and Handswitch

6.1 Injector Head Control

Controls located on the injector head unit.

6.2 Injector Head Components

Description of the parts comprising the injector head.

6.3 Handswitch

Function and operation of the hand-held control.

12 Removing Disposables

13 Advanced Operations

13.1 System Setup

Configuring overall system settings.

13.2 Setup of P3T Software Functionality

Configuration for Personalized Patient Protocol Technology.

13.3 Protocol Manager Setup

Managing and organizing injection protocols.

13.4 Fluid Delivery Setup

Configuring fluid delivery system parameters.

13.5 Informatics Setup

Setting up data management and connectivity.

13.6 Help

Accessing the system's help resources.

13.7 Fluid A

Managing contrast media settings.

14 Troubleshooting

14.1 Injector Head Error Indication

Understanding error signals from the injector head.

14.2 Error Screen

Displayed messages and codes for system errors.

14.3 Other Troubleshooting Tips

Additional guidance for resolving common issues.

14.4 System Tones

Explanation of auditory alerts and signals.

15 Cleaning and Maintenance

15.2 Daily and In the Case of Visible Contamination

Daily cleaning and disinfection routines.

15.3 Daily

Daily inspection and cleaning procedures.

15.4 Monthly

Monthly maintenance checks and procedures.

15.5 Annually

Annual maintenance and calibration tasks.

15.6 Reinstalling the System in Another Room

Instructions for moving and setting up the system.

16 Options and Accessories

16.1 Mounting Options

Various ways to physically install the system.

16.2 Injector Head Extension Cables

Cables for extending injector head reach.

16.3 Workstation Extension Cables

Cables for extending workstation reach.

16.4 Accessories

List of available system add-ons.

16.5 Manuals

Other documentation related to the system.

16.6 Sterile Disposables

List of single-use items.

17 Specifications

17.1 Workstation Specifications

Technical details of the workstation.

17.2 Workstation with Pod Specifications

Technical details for workstations with pods.

17.3 Base Unit Specifications

Technical details of the base unit.

17.4 Injector Head Specifications

Technical details of the injector head.

17.5 Environmental Specifications

Operating and storage conditions.

17.6 Over and Under Infusion Protection

Safety features against incorrect fluid delivery.

17.7 System Fluid Performance

Performance metrics related to fluid delivery.

17.8 Power Cable Specifications

Details about the power cable requirements.

17.9 Cybersecurity and IT Network Connection

Security measures for network and data.

17.10 Fuse Specification

Information about the system's fuse.

7 Powering Up and Shutting Down the System

7.1 Power Up the System

Steps to turn on the injection system.

7.2 Shut Down the System

Procedures for safely turning off the system.

7.3 Restore from Injector Shutdown

Steps to recover from injector shutdown.

8 Protocol Management

8.1 Create or Edit a Protocol

How to define and modify injection protocols.

8.2 Save a Protocol

Process for saving created or edited protocols.

8.3 Recall a Saved Protocol

Steps to load previously saved protocols.

8.4 DualFlow

Managing protocols with simultaneous contrast and saline delivery.

9 Preparing for Injection

9.1 Control Room Preparation

Tasks performed in the control room before injection.

9.2 Scan Room Preparation

Tasks performed in the scan room before injection.

10 Arming and Injecting

10.1 Add Volume Indicator

Notification for insufficient fluid volume.

10.2 Arm the Injector

Steps to prepare the injector for injection.

10.3 Initiating an Injection

How to start the fluid injection process.

10.4 Operator-Initiated Hold

Pausing the injection manually.

10.5 Injection Aborted

Information on what happens when an injection is stopped.

10.6 Viewing Injection Progress

Monitoring the status of an ongoing injection.

10.7 Viewing Reminders

How to see system-generated alerts.

11 Completing an Injection

11.1 Injection Complete

What occurs when an injection finishes successfully.

11.2 Injection Aborted

Screen displayed when an injection is prematurely stopped.

11.3 Exiting Injection Complete

Procedures after the injection completion screen.

13 Advanced Operations

13.1 System Setup

Configuring overall system settings.

13.2 Setup of P3T Software Functionality

Configuration for Personalized Patient Protocol Technology.

13.3 Protocol Manager Setup

Managing and organizing injection protocols.

13.4 Fluid Delivery Setup

Configuring fluid delivery system parameters.

13.5 Informatics Setup

Setting up data management and connectivity.

13.6 Help

Accessing the system's help resources.

13.7 Fluid A

Managing contrast media settings.

14 Troubleshooting

14.1 Injector Head Error Indication

Understanding error signals from the injector head.

14.2 Error Screen

Displayed messages and codes for system errors.

14.3 Other Troubleshooting Tips

Additional guidance for resolving common issues.

14.4 System Tones

Explanation of auditory alerts and signals.

15 Cleaning and Maintenance

15.2 Daily and In the Case of Visible Contamination

Daily cleaning and disinfection routines.

15.3 Daily

Daily inspection and cleaning procedures.

15.4 Monthly

Monthly maintenance checks and procedures.

15.5 Annually

Annual maintenance and calibration tasks.

15.6 Reinstalling the System in Another Room

Instructions for moving and setting up the system.

16 Options and Accessories

16.1 Mounting Options

Various ways to physically install the system.

16.2 Injector Head Extension Cables

Cables for extending injector head reach.

16.3 Workstation Extension Cables

Cables for extending workstation reach.

16.4 Accessories

List of available system add-ons.

16.5 Manuals

Other documentation related to the system.

16.6 Sterile Disposables

List of single-use items.

17 Specifications

17.1 Workstation Specifications

Technical details of the workstation.

17.2 Workstation with Pod Specifications

Technical details for workstations with pods.

17.3 Base Unit Specifications

Technical details of the base unit.

17.4 Injector Head Specifications

Technical details of the injector head.

17.5 Environmental Specifications

Operating and storage conditions.

17.6 Over and Under Infusion Protection

Safety features against incorrect fluid delivery.

17.7 System Fluid Performance

Performance metrics related to fluid delivery.

17.8 Power Cable Specifications

Details about the power cable requirements.

17.9 Cybersecurity and IT Network Connection

Security measures for network and data.

17.10 Fuse Specification

Information about the system's fuse.

18 Addendum – Compliance to IEC 60601-1-2: 3rd and 4th Editions

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